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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01828983
Other study ID # W81XWH-11-2-0087
Secondary ID
Status Completed
Phase N/A
First received April 4, 2013
Last updated October 20, 2017
Start date April 2011
Est. completion date June 2015

Study information

Verified date October 2017
Source Memphis VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deployment impacts both service member and family, and the cost can be high. Spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. The study will compare telephone support groups to online education sessions. The study will enroll 160 spouses. In the Telephone Support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. Education Only online sessions will provide the same education content, without skills building or support. Content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. Outcomes will include resilience, depression, anxiety and coping behaviors. Telephone data collection will be conducted at baseline, six and twelve months.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date June 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member

- deployed at least six months

Exclusion Criteria:

- living as married for at least one year before deployment

Study Design


Intervention

Behavioral:
Telephone support groups

Other:
Education webinars


Locations

Country Name City State
United States Memphis VA Medical Center Memphis Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Memphis VA Medical Center United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spouse Self-report of Resilience Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience. Baseline, 6 months
Primary Spouse Self Report of Anxiety Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety. baseline, and 6 months
Primary Spouse Self Report of Depression Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms. Baseline, 6 months
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